The scope of the so-called “safe harbor” enacted as part of the Hatch-Waxman Act is one
that has evolved in the more than thirty years since the law was enacted. Found in Section 271(e) of the Patent Act, the law provides that:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United
States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a
Federal law which regulates the manufacture, use, or sale of drugs...

The Supreme Court has expanded the scope of
the law to include medical devices and, for drugs, “lead compounds” early in the drug development chain. The question of whether activities
undertaken post-approval are included has not been subject to Supreme Court review, and this week the Court declined such review in a case captioned
Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc. The Court decided not to review this issue mindfully, as the Petitioner fashioned
their question to the Court to be:

Whether the safe harbor protects a generic drug
manufacturer’s bioequivalence testing that is performed only as a condition of maintaining FDA approval and is documented in records that must be
submitted to the FDA upon request.

The case involved enoxaparin, an anticoagulant drug marketed since 1993 under
the brand name Lovenox. Momenta marketed the first generic version of the drug and sought to block additional generic entrants by asserting U.S. Patent No.
7,575,886, which claimed methods for ensuring that each batch of the drug met quality standards. The District Court held that Amphastar’s activities
fell within the scope of the safe harbor, but the Federal Circuit disagreed, based on its interpretation of the purpose of the statute from the legislative
history:

The purpose of sections 271(e)(1) and (2) is to establish that
experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a
patent infringement.

The opinion noted that there were exceptions to the safe harbor protections, including
research tools not subject to FDA approval and information “routinely reported” to the FDA post-approval. It was in this latter category
that the court found Amphastar’s activities to belong, and hence they did not fall within the safe harbor. This decision was based in part on the
panel’s apprehension that deciding in Amphastar’s favor would “result in manifest injustice” because it would be the first case to
have § 271(e)(1) encompass “activities related to ongoing commercial manufacture and sale.” The majority’s conclusion was supported by
the Federal government as amicus, wherein “the government argued that the routine use of a patented testing process in the commercial
manufacture of a drug is not ‘reasonably related to the development and submission of information to [the] FDA’ and thus not shielded from
liability by § 271(e)(1).’”

Denial of certiorari does not connote agreement by the
Supreme Court, of course, but until the Court decides to address this issue the question of what activities are not within the safe harbor remains unclear,
particularly with regard to those such as safety testing that are performed post-approval. In view of this decision, the more routine the testing and results
reported to the FDA the less likely it will be that those activities will be protected by the Section 271(e)(1) safe harbor. But such ex post facto
justifications should be less than satisfying (or reassuring) to pharmaceutical company decision-makers when determining whether to license patented
post-approval testing methods, or when such methods become sufficiently standard that the FDA requires their use to maintain approval. Such a “rock-
and-a-hard-place” situation belies the very concept of a “safe harbor” and will result in increased uncertainty as the extent of such
post-approval testing increases.